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Partial AUCs in Long-Acting Injectables: Rationale, Challenges, Variability, Usefulness, and Clinical Relevance.
Pharmaceutics
December 2024
Pharmathen SA, 31 Spartis Str., 14452 Metamorfosi Attica, Greece.
Regulatory authorities typically require bioequivalence to be demonstrated by comparing pharmacokinetic parameters like area under the plasma concentration-time curve (AUC) and maximum plasma concentration (C). Because in certain cases, AUC and C alone may not be adequate to identify formulation differences in early and/or late segments of the dosing interval, partial AUCs (pAUCs) have been proposed as additional metrics to evaluate bioequivalence. Even though cut-off points for pAUCs are usually decided based on clinical relevance, the identification of the correct cut-off range remains elusive in many other cases and tends to contribute to increased pAUC estimate variabilities.
View Article and Find Full Text PDFSPATIAL MEMORY RECOVERY IN AGED MALE RATS TREATED WITH LEUPROLIDE ACETATE, A GNRH AGONIST.
Acta Endocrinol (Buchar)
January 2025
Universidad Autónoma de Aguascalientes, Centro de Ciencias Básicas, Department of Physiology and Pharmacology.
Context: Studies indicate a decrease in spatial memory across species as they age. Moreover, consistent administration of Gonadotropin-releasing hormone (GnRH) improves learning abilities in older rats that have undergone gonadectomy.
Objective: The aim of this study was to investigate the effects of the GnRH agonist, leuprolide acetate (LA) on spatial memory in aged intact male rats and the expression of proteins associated with hippocampal plasticity.
A 2024 Update on US FDA Implementation of Partial Area Under the Curve Into Bioavailability and Bioequivalence Assessments.
Clin Pharmacol Ther
January 2025
Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Comparisons of maximum drug concentration (C) and total area under the concentration vs. time curve (AUC) may be inadequate for bioavailability (BA)/bioequivalence (BE) assessments in cases where the shape of the pharmacokinetic (PK) profile of a drug impacts the clinical performance. In such cases, partial area under the concentration vs.
View Article and Find Full Text PDFSuccessful Management of Disseminated Intravascular Coagulation in Metastatic Castrate-Resistant Prostate Cancer With Lutetium-177: A Case Report and Review of the Literature.
Cureus
December 2024
Department of Internal Medicine, Division of Hematology and Oncology, University of Texas Southwestern Medical Center, Dallas, USA.
Disseminated intravascular coagulation (DIC) is a hematological disorder characterized by the abnormal activation of the coagulation system, which leads to widespread clotting and subsequent consumption coagulopathy. DIC is often associated with the progression of prostate cancer and can be a life-threatening condition. In this case report, we present a patient with recurrent DIC in the setting of advanced prostate cancer.
View Article and Find Full Text PDFRecent Trends in Medical Management of Endometriosis.
J Obstet Gynaecol India
December 2024
Nowrosjee Wadia Maternity Hospital, Mumbai, India.
Endometriosis affects about 10 percent women in the reproductive age group globally and approximately 42 million in India. Managing the patient's pain symptoms associated with endometriosis appears to be the cornerstone in endometriosis disease management. The ideal medical treatment in endometriosis would be suppressing estradiol enough to alleviate symptoms of endometriosis but maintain sufficient levels to mitigate hypoestrogenic side effects.
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